Percutaneous catheter directed intravascular occlusion device

ABSTRACT

Embodiments of the present invention provide medical devices and methods for occluding a target site are provided. For example, the medical device may include a tubular member having proximal and distal ends and at least one plane of occlusion. The at least one plane of occlusion may be configured to substantially occlude the patent ductus arteriosus in less than about 1 minute. In addition or alternatively, the tubular member may consist of a single layer of material and be configured to be constrained within a catheter having an outer diameter of less than about 4 French for percutaneous delivery to the patent ductus arteriosus.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of and priority to U.S. ProvisionalApplication No. 61/022,164, filed on Jan. 18, 2008, which is hereinincorporated by reference in its entirety.

BACKGROUND OF THE INVENTION I. Field of the Invention

Embodiments of the present invention generally relate to medical devicesfor treating certain target sites and, more particularly, relates tointravascular occlusion devices for selective occlusion of a target siteanywhere in the body's circulatory system.

II. Description of the Related Art

A wide variety of intravascular devices are used in various medicalprocedures. Certain intravascular devices, such as catheters andguidewires, are generally used simply to deliver fluids or other medicaldevices to specific locations within a patient's body, such as aselective site within the vascular system. Other, frequently morecomplex, devices are used in treating specific conditions, such asdevices used in removing vascular occlusions or for treating septaldefects and the like.

In certain circumstances, it may be necessary to occlude a patient'slumen, vessel, chamber, channel, hole, or cavity such as to stop bloodflow there through. One such condition known in the art is a patentductus arteriosus (PDA), which is essentially a condition wherein twoblood vessels, most commonly the aorta and pulmonary artery adjacent theheart, have a blood flow shunt between their lumens. Blood can flowdirectly between these two blood vessels through the passageway,compromising the normal flow of blood through the patient's vessels.Other physiologic conditions in the body occur where it is also desirousto occlude a vessel to prevent blood flow through the vessel.

Various devices have been developed for occlusion of vessels in variouslocations within the vasculature. Despite these techniques forfacilitating occlusion, it would be advantageous to provide an improvedocclusion device which offers increased flexibility, improved retention,alternate delivery methods and improved thrombogenicity within a vessel,chamber, channel, hole, cavity, or the like.

SUMMARY OF THE INVENTION

Embodiments of the present invention may be well suited for theselective occlusion of a vessel, lumen, channel, hole, cavity, or thelike. One example, without limitation, of such a condition is a PatentDuctus Arteriosus (hereinafter PDA). Another example is a vessel, lumen,channel, or hole through which blood flows from one vessel to anothervessel such as an Atrial Septal Defect (herein after ASD) or aVentricular Septal Defect (herein after VSD). Other examples could be anArterial Venous Fistula (AVF), Arterial Venous Malformation (AVM), aPatent Foramen Ovale (PFO), or a Para-Valvular Leak (PVL).

According to one embodiment, a medical device for occluding a patentductus arteriosus is provided. The medical device includes a tubularmember having proximal and distal ends and comprises at least one planeof occlusion. The at least one plane of occlusion may be configured tosubstantially occlude the patent ductus arteriosus in less than about 1minute. In addition or alternatively, the tubular member may consist ofat least one layer and be configured to be constrained within a catheterhaving an outer diameter of about 5 French and even about 4 French orsmaller for percutaneous delivery.

According to various aspects of the medical device, the tubular membercomprises a disk shaped portion having a first cross-sectional dimensionon at least one of the proximal and distal ends and an adjacentgeometrical shaped portion (e.g., a cylinder) having a secondcross-sectional dimension smaller than the first cross-sectionaldimension. The medical device may further include a transition segmentdisposed between the disk shaped portion and the geometrical shapedportion, wherein the disk and geometrical shaped portions are connectedby the transition segment having a cross-sectional dimension smallerthan both the disk diameter and geometrical shaped portioncross-sectional dimension. The tubular member may include afrustroconical shaped disk on each of the proximal and distal ends,wherein the geometrical shaped portion is disposed therebetween andconnected to the frustroconical shaped disks with respective transitionsegments.

According to additional aspects of the medical device, the tubularmember consists of a single layer of braided fabric comprising aplurality of braided metal strands. The metal strands may be a materialselected from the group consisting of stainless steel, nickel based,cobalt based, nickel-titanium, shape memory, and super-elasticmaterials. The tubular member may include a plurality of planes ofocclusion. For instance, a plurality of planes of occlusion may beconfigured to be positioned outside of the patent ductus arteriosus anda plurality of planes of occlusion are configured to be positionedwithin a cavity defined by the patent ductus arteriosus.

Another embodiment of the present invention is directed to a deliverysystem for delivering a medical device for occluding a patent ductusarteriosus. The delivery system includes a delivery device coupled tothe medical device, wherein the medical device consists of a singlelayer of material, and a catheter configured to overlie the deliverydevice and constrain the medical device therein. The medical device isconfigured to be deployed from the catheter, wherein the delivery deviceand catheter are configured to be delivered bi-directionally to thepatent ductus arteriosus either transarterially or transvenously and todeploy the medical device at least partially within the patent ductusarteriosus.

According to one aspect of the delivery system, the catheter has anouter diameter of about 5 French and even about 4 French or smaller. Thedelivery device and catheter may be configured to be delivered to thepatent ductus arteriosus over a guidewire. Further, the catheter may beaxially displaceable relative to the delivery device such that themedical device is configured to be deployed from the catheter inresponse to displacement of the catheter with respect to the deliverydevice.

Another embodiment of the present invention is directed to a method foroccluding a patent ductus arteriosus. The method includes providing amedical device consisting of a single layer of material and constrainingthe medical device from a preset expanded configuration to a reducedconfiguration. The method also includes positioning the constrainedmedical device in a catheter, the catheter configured to be deliveredbi-directionally, either transarterially or transvenously, anddelivering the medical device to the patent ductus arteriosus eithertransarterially or transvenously. The method further includes deployingthe medical device from the catheter at least partially within thepatent ductus arteriosus such that the tubular member returns to thepreset expanded configuration.

Aspects of the method include deploying the medical device such that atleast one plane of occlusion is positioned outside the patent ductusarteriosus and at least one plane of occlusion is positioned within acavity defined within the patent ductus arteriosus. The deploying stepmay include detaching a delivery system positioned within the catheterand coupled to the medical device, while the delivering step may includedelivering the medical device over a guide wire. The method may furtherinclude imaging the patent ductus arteriosus using at least one oftwo-dimensional intracardiac echocardiography, angiography, magneticresonance imaging, transesphogeal echocardiograpy, or Doppler color flowmapping. Moreover, the method may include verifying occlusion of thepatent ductus arteriosus by injecting a radiopaque contrast mediathrough the catheter and into the left atrium adjacent the deployedmedical device and observing with angiography whether contrast entersthe cavity defined by the patent ductus arteriosus and further whetherany contrast within the cavity is stagnant.

BRIEF DESCRIPTION OF THE DRAWINGS

Having thus described the invention in general terms, reference will nowbe made to the accompanying drawings, which are not necessarily drawn toscale, and wherein:

FIG. 1A depicts an occlusion device according to one embodiment of thepresent invention;

FIG. 1B is a cross-sectional view of the device of FIG. 1A;

FIG. 2 is a partial sectional view of a heart, with an occlusion devicepositioned within the septum, according to one embodiment of the presentinvention;

FIGS. 3A-3E are views of an occlusion device positioned within variousportions of the patient's anatomy according to embodiments of thepresent invention;

FIG. 4 is an elevational view of an occlusion device according to oneembodiment of the present invention;

FIG. 4A illustrates exemplary dimensions for the occlusion device shownin FIG. 4 according to various embodiments of the present invention;

FIG. 5 is a plan view of a delivery system according to an embodiment ofthe present invention;

FIG. 5A illustrates exemplary dimensions for a delivery system accordingto various embodiments of the present invention;

FIG. 6 is a partial sectional view of a heart, with an occlusion devicepositioned within the septum, according to one embodiment of the presentinvention;

FIG. 7 is a partial sectional view of a heart, with an occlusion devicebeing delivered transvenously, according to one embodiment of thepresent invention; and

FIG. 8 is a partial sectional view of a heart, with an occlusion devicebeing delivered transarterially, according to one embodiment of thepresent invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention now will be described more fully hereinafter withreference to the accompanying drawings, in which some, but not allembodiments of the invention are shown. Indeed, this invention may beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will satisfy applicable legalrequirements. Like numbers refer to like elements throughout.

Embodiments of the present invention may provide an improvedpercutaneous catheter directed intravascular occlusion device for use inthe vasculature in patients' bodies, such as blood vessels, channels,lumens, a hole through tissue, cavities, and the like, such as a patentductus arteriosus (PDA). Other physiologic conditions in the body occurwhere it is also desirous to occlude a vessel or other passageway toprevent blood flow into or therethrough. These device embodiments may beused anywhere in the vasculature where the anatomical conditions areappropriate for the design.

The device may include one or more layers of occlusive material, whereineach layer may be comprised of any material that is configured tosubstantially preclude or occlude the flow of blood so as to facilitatethrombosis. As used herein, “substantially preclude or occlude flow”shall mean, functionally, that blood flow may occur for a short time,but that the body's clotting mechanism or protein or other body depositson the occlusive material results in occlusion or flow stoppage afterthis initial time period. For instance, occlusion may be clinicallyrepresented by injecting a contrast media into the upstream lumen of thedevice and if little or no contrast media flows through the device wallafter a predetermined period of time, then the position and occlusion ofthe device is adequate as would be recognized by one of ordinary skillin the art. More specifically, the time for occlusion could begin afterdeployment of the medical device, such as after the device has expandedand engaged the lumen and the delivery device has been disconnected,until no contrast media (as observed with fluoroscopy) flows through thedevice. For instance, if the medical device is implanted within a lumenand contrast media is injected on one side of the device (e.g., a highpressure side) but no contrast media is observed on the opposite side ofthe device (e.g. a low pressure side), then the device has substantiallyprecluded or occluded blood flow through the device. Thus, if themedical device is implanted within a PDA and contrast media is injectedinto the aorta and does not flow through the device to the pulmonaryartery or remains stagnant within the device, then flow through the PDAis substantially precluded or occluded. According to one embodiment ofthe present invention, the device is configured to occlude at least aportion of a vessel, a channel, a lumen, an opening, or a cavity in lessthan about 10 minutes and even less than about 5 minutes with observedocclusions in testing as low as within about 1 minute. Thus, in oneembodiment, there is not “immediate occlusion,” as the device does notimmediately obstruct all blood flow but, rather, slows the flow of bloodin order for occlusion to occur as described above. Such immediateocclusion may result in problems in fixation or positioning of thedevice in the lumen or may result in suction or the complete stoppage offlow which may be undesirable in some circumstances.

According to one embodiment, the device comprises at least one layer ofmetal fabric formed of a plurality of wire strands having apredetermined relative orientation with respect to one another. However,it is understood that according to additional embodiments of the presentinvention, the device may be formed using various techniques. Forexample, the device could be etched or laser cut from a tube such as toform an interstice geometry, or the device could comprise an occlusivematerial coupled to a scaffolding structure or a plurality of slices ofa tubular member coupled together, such as via gluing. Moreover, it isunderstood that the device may comprise one or more layers of occlusivematerial such that the device may be a variety of occluding materialscapable of at least partially inhibiting blood flow therethrough inorder to facilitate the formation of thrombus.

Although the term “strand” is discussed herein, “strand” is not meant tobe limiting, as it is understood the fabric may comprise one or morewires, cords, fibers, yarns, filaments, cables, threads, or the like,such that such terms may be used interchangeably.

According to one embodiment, the occluding material is at least onelayer of metal fabric including a plurality of strands, such as two setsof essentially parallel generally helical strands, with the strands ofone set having a “hand”, i.e., a direction of rotation, opposite that ofthe other set. The strands may be braided, interwoven, or otherwisecombined to define a generally tubular fabric.

The pitch of the strands (i.e., the angle defined between the turns ofthe strands and the axis of the braid) and the pick of the fabric (i.e.,the number of wire strand crossovers per unit length) may be adjusted asdesired for a particular application. The wire strands of the metalfabric used in one embodiment of the present method may be formed of amaterial that is both resilient and can be heat treated to substantiallyset a desired shape. Materials which may be suitable for this purposemay include a cobalt-based low thermal expansion alloy referred to inthe field as Elgiloy, nickel-based high temperature high-strength“superalloys” commercially available from Haynes International under thetrade name Hastelloy, nickel-based heat treatable alloys sold under thename Incoloy by International Nickel, and a number of different gradesof stainless steel. A factor in choosing a suitable material for thewires strands is that the wires retain a suitable amount of thedeformation induced by the molding surface (as described below) whensubjected to a predetermined heat treatment and elastically return tosaid molded shape after substantial deformation.

One class of materials that meets these qualifications is so-calledshape memory alloys. One particularly preferred shape memory alloy foruse in the present method is Nitinol. NiTi alloys are also veryelastic—they are said to be “superelastic” or “pseudoelastic”. Thiselasticity may allow the device to return to a preset expandedconfiguration for deployment following passage in a distorted formthrough a delivery catheter. Moreover, other suitable materials includethose that are compatible with magnetic resonance imaging (MRI), as somematerials may cause heat or torque resulting from performing MRI, andsome materials may distort the

MRI image. Thus, metallic and/or non-metallic materials that reduce oreliminate these potential problems resulting from using MRI may beemployed.

In forming a medical device according to one embodiment of the presentinvention, an appropriately sized piece of the fabric is cut from thelarger piece of fabric which is formed, for example, by braiding wirestrands to form a long tubular braid. When cutting the fabric to thedesired dimensions, care should be taken to ensure that the fabric willnot unravel. One can use a number of methods, including solder, braze,weld, coat, glue, clamp, tie or otherwise affix the ends of the desiredlength together (e.g., with a biocompatible cementitious organicmaterial).

Furthermore, one or more layers of fabric may be employed to form amedical device. For example, two layers of metal fabric could beseparately woven into tubular members, with one tubular member coaxiallydisposed within the second tubular member. For further discussionregarding a multi-layer braided device and techniques for fabricatingsuch a device, see U.S. Patent Appl. Publ. No. 2007/0265656 to Amplatzet al., which is hereby incorporated in its entirety by reference.

The tubular braid used to fabricate occlusion devices according to oneembodiment of the present invention may range from wire having adiameter of about 0.0015 to 0.005 in., preferably in the range of about0.003 to 0.0045 in. The number of wires in the tubular braid may varyfrom about 36 to 144 but preferably is in the range of about 72 to 144.The pick count of the braid may vary from 30 to 100, and the fabric mayhave an average area between supporting fibers of about 0.0015 sq cm.and 0.10 sq cm.

Once an appropriately sized piece of the metal fabric is obtained, thefabric is deformed to generally conform to a surface of a moldingelement. Deforming the fabric will reorient the relative positions ofthe wire strands of the metal fabric from their initial order to asecond, reoriented configuration. The shape of the molding elementshould be selected to deform the fabric into substantially the shape ofthe desired medical device when unconstrained. Once the molding elementis assembled with the metal fabric generally conforming to a moldingsurface of that element, the fabric can be subjected to a heat treatmentwhile it remains in contact with that molding surface. After the heattreatment, the fabric is removed from contact with the molding elementand will substantially retain its shape in a deformed state.

With reference to FIGS. 1A and 1B, the device 300′ in its relaxed,unstretched state has two disks 302′ and 304′ aligned in spacedrelation, linked together by a cylindrical segment 306′. The length ofthe cylindrical segment 306′ may approximate the thickness of the atrialseptum. The proximal 302′ and distal 304′ disks may have an outerdiameter sufficiently larger than the cavity, opening, or the like toprevent dislodgement of the device. The disks 302′ and 304′ aregenerally frustroconical in configuration, with the larger diameterportions facing one another. Thus, as shown in FIG. 4, the disks 302′and 304′ taper from a smaller diameter A to a larger diameter C. Theangle extending between diameters A and C may vary and may be, forexample, between about 20 and 40 degrees. Similarly, the distancebetween the smaller and larger diameter surfaces of each disk 302′ and304′ may vary. The disks 302′ and 304′ are configured to extend inwardlyto slightly overlap the cylindrical segment 306′, which can be moreclearly seen in the cross-sectional view of FIG. 1B. As also shown inFIG. 1B, the cylindrical segment 306′ connects with each of the disks302′ and 304′ at a diameter 309′ which is smaller than both the diameterof the cylindrical segment and the disks. This configuration may allowthe disks 302′ and 304′ to easily pivot about diameters 309′ to allowthe disks to align themselves with anatomical vessel walls that are notperpendicular to the aperture therebetween. FIGS. 4 and 4A illustratethe device 300′ and various exemplary dimensions that may be employedaccording to various aspects of the present invention.

According to one embodiment, the ends of this braided fabric device 300′may be welded or clamped together with clamps 308′ and 310′ to avoidfraying. However, it is understood that the ends may alternately be heldtogether by other techniques, as discussed above. The clamp 310′ tyingtogether the wire strands at the proximal end also serves to connect thedevice to a delivery system, which is described in further detail below.In the embodiment shown, the clamp 310′ is generally cylindrical inshape and has a recess for receiving the ends of the metal fabric tosubstantially prevent the wires comprising the woven fabric from movingrelative to one another. The clamp 310′ may also have a threaded surfacewithin the recess. The threaded recess is adapted to receive and engagethe threaded distal end of a delivery device.

Those skilled in the art will appreciate that in order to speed up theocclusion of the vessel device, the device may be coated with a suitablethrombogenic agent, filled with a polyester fiber, braided with anincreased number of wire strands, or include multiple layers of fabric.For example, the device may include one or more layers of thrombogenicmaterial such as, but not limited to, polyester fiber positioned withinthe disks 302′ and 304′ and/or the cylindrical segment 306′. Inparticular, a layer of polyester fiber may be sized and configured to bepositioned within each of the disks 302′ and 304′ and/or the cylindricalsegment 306′ and sutured circumferentially about its periphery and aboutthe inner circumference of the body portion and disk portion,respectively. The polyester fiber is flexible and may be easilycollapsed with the device for delivery through a catheter. Theinterwoven fiber may attach to a clot to retain the clot firmly withinthe device as it forms the occlusion.

Therefore, the device may include a plurality of planes of occlusion. Aplane of occlusion may be any surface, whether flat or irregular inshape, that may be oriented generally transverse to the flow of blood soas to facilitate the formation of thrombus. For example, the disks 302′and 304′ and the cylindrical segment 306′ may include at least one planeof occlusion, such as each surface or layer of the disks and eachsurface or layer of the cylindrical segment. Moreover, additional layersof fabric and/or each layer of polyester fiber within the disks and/orcylindrical segment may add additional planes of occlusion. Furthermore,the one or more of planes of occlusion associated with the disks 304′and 306′ may be positioned to overlie a cavity, an opening, or the like,while the one or more planes of occlusion associated with thecylindrical segment 306′ may be positioned within the cavity, opening,or the like. A delivery system 100, such as that as shown in FIG. 5 maybe used to deploy the device 300′ in the patient's body. The deliverysystem 100 can take any suitable shape and may include a tube, sheath,delivery catheter 102, or the like, a metal shaft such as a guidewire106, a loader 104, and/or vise 112, and may be used to deliver thedevice into the patient's lumen. The distal end 114 of the deliverysystem 100 may be curved, as shown in FIG. 5 in order to facilitatetransarterial or transvenous delivery to the PDA. FIG. 5A alsoillustrates exemplary dimensions for the delivery system that may beused for various devices according to various embodiments of the presentinvention.

According to one embodiment, the device is loaded into the lumen bystretching the same to put it in an elongated condition. The device maybe inserted into the lumen during the procedure or preassembled at amanufacturing facility, in that the devices of the present invention donot take on a permanent set when maintained in a compressed state.According to one embodiment, the device 300′ may be configured to bereceived within a catheter having an outer diameter of less than about 5French and even less than about 4 French. When the device is deployedout the distal end of the catheter, the device will still be retained bythe delivery system. Once the proper position of the device in thevessel, body organ, or the like is confirmed, the shaft of the deliverysystem can be rotated about its axis to unscrew the clamp 308′ or 310′from the threaded end of the delivery system. Of course the threadedconnection could be at either end of the device depending on theanatomical situation and the desired or available means of access to thetreatment site.

By keeping the device 300′ attached to the delivery system, the operatormay still retract the device back into a delivery catheter forrepositioning if it is determined that the device is not properlypositioned in the first attempt. In instances where the device isimproperly deployed on a first try, the device may be recovered bypulling the delivery system 100 proximally, thereby retracting thedevice back into the delivery catheter prior to a second attempt atpositioning the device relative to the vessel, body organ, or the like.The threaded attachment may also allow the operator to control themanner in which the device is deployed out of the distal end of thedelivery catheter. When the device exits the delivery catheter it willtend to resiliently return to an expanded shape which was set when thefabric was heat treated. When the device springs back into this shape,it may tend to act against the distal end of the catheter, effectivelyurging itself forward beyond the end of the catheter. This spring actioncould conceivably result in improper positioning of the device. Sincethe threaded clamps 308′ and 310′ can enable the operator to maintain ahold on the device during deployment, the spring action of the devicecan be controlled and the operator can control the deployment to ensureproper positioning.

It is understood that the delivery system 100 may include variousalternative aspects for delivering the device. For example, the deliverysystem may include a touhy borst and/or hemostatis valve 108 and a stopcock 110 for facilitating the delivery or withdrawal of fluids or use ofinstruments with the delivery device. Optionally, the device 300′ couldbe configured with a hollow inner clamp member at one or both ends toallow a push wire or guidewire 106 to freely pass therethrough.According to one embodiment, the delivery catheter 102 sheath may have a0.001 in thick inner layer of PTFE to lower friction for ease of devicepassage therethrough. For a discussion of a delivery device according toadditional variations of the present invention, Applicants herebyincorporate in its entirety, U.S. patent application Ser. No. 11/827,590to Amplatz et al., filed Jul. 12, 2007.

Generally, a method in accordance with one embodiment of the presentinvention includes a method of treating a physiological condition of apatient. In accordance with this method, a medical device suitable fortreating the condition, which may be substantially in accordance withone of the embodiments described in detail above, is selected. Thedevice may be delivered and properly placed using two-dimensional ICE,MRI, transesphogeal echocardiograpy, angiography, and/or Doppler colorflow mapping. With the advent of two-dimensional ICE, MRI,trans-esophageal echocardiography, bi-plane angiography, and Dopplercolor flow mapping, the approximate anatomy of the defect can bevisualized. The device that is employed will be based on the approximatesize of the vessel, cavity, or the like to be occluded. Once theappropriate medical device is selected, a catheter may be positionedwithin a channel in patient's body to place the distal end of thecatheter adjacent the desired treatment site, such as immediatelyadjacent or within the wall of the septum. According to one embodiment,FIGS. 7 and 8 illustrate that the device 300′ may be delivered with thedevice 100 either via the aortic side by femoral artery access (FIG. 8)or via pulmonary artery access (FIG. 7).

The medical device can be collapsed into its collapsed configuration andinserted into the lumen of the catheter. The collapsed configuration ofthe device may be of any shape suitable for easy passage through thelumen of a catheter and proper deployment out the distal end of thecatheter. For example, the device may have a relatively elongatedcollapsed configuration wherein the device is stretched along its axesfor insertion into the catheter. This collapsed configuration can beachieved simply by stretching the device generally along its axis, e.g.,by manually grasping opposing ends of the device and pulling them apart,which will tend to collapse the disks 302′ and 304′ and cylindricalsegment 306′ of the device 300′ inwardly toward the device's axis. Inthis regard, the device is not unlike “Chinese handcuffs”, which tend toconstrict in diameter under axial tension.

The medical device may also be collapsed by drawing the delivery systemcoupled to the medical device proximally into an introducer tube (notshown) extending over the delivery system shaft. Drawing the deliverysystem proximally pulls the device into the introducer tube sized withan inside diameter to hold the medical device to a diameter to allowforward loading into a catheter.

Once the medical device is collapsed and inserted into the catheter, itmay be urged along the lumen of the catheter toward the distal end ofthe catheter. This may be accomplished by using a delivery system or thelike removably connected to the device to urge it along the catheter.When the device begins to exit the distal end of the catheter, which ispositioned adjacent the desired treatment site, it will tend toresiliently return substantially entirely to its preset expandedconfiguration. Superelastic alloys, such as Nitinol, are particularlyuseful in this application because of their ability to readily return toa particular configuration after being elastically deformed to a greatextent. Hence, simply urging the medical device out of the distal end ofthe catheter tends to properly deploy the device at the treatment site.

Although the device will tend to resiliently return to its initialexpanded configuration (i.e., its shape prior to being collapsed forpassage through the catheter), it should be understood that it may notalways return entirely to that shape. For example, the cylindricalsegment 306′ is intended to have a maximum outer diameter in itsexpanded configuration at least as large as and preferably larger than,the inner diameter of the lumen in which it is to be deployed. If such adevice is deployed in a vessel, body organ, or the like having a smalllumen, the lumen will prevent the device from completely returning toits expanded configuration. Nonetheless, the device would be properlydeployed because it would engage the inner wall of the lumen to seat thedevice therein, as detailed above.

If the device is to be used to permanently occlude a channel in thepatient's body, such as the device 300′, one can simply disconnect thedelivery system by reversing the reversible connection to the device andretract the catheter and delivery system from the patient's body. Thiswill leave the medical device deployed in the patient's vascular systemso that it may occlude the blood vessel or other channel in thepatient's body.

Embodiments shown in FIGS. 2, 3A-3E, and 6-8 illustrate how the disks302′ and 304′ can assume a non-parallel relationship to intimatelyengage opposed walls of a septum 318 of non-uniform thickness and withthe central cylindrical portion 306′ expanded against the walls of theseptum. The disks 302′ and 304′ are tapered towards the vessel, lumen,channel, hole, cavity, or the like, which allows the device to conformto a wall thickness (e.g., septum) having various lengths. Furthermore,the flexibility between the disks 302′ and 304′ and the cylindricalsegment 306′ allows the device 300′ to be adaptable to a variety ofabnormalities, which is illustrated by FIGS. 3A-3E and 6-8.

According to one particular embodiment of the present invention, amethod for delivering a device 300′ for treating a PDA is described,although it is understood that various techniques could be usedaccording to additional aspects of the present invention. For example,the method generally involves performing a right heart catheterizationand determining the diameter and length of the PDA using angiography.The appropriate sized device may be chosen based on the diameter andlength determinations. A guidewire may then be introduced using anarterial or venous approach and crossed over the PDA. The deliverycatheter may be delivered over the guidewire and across the PDA. Theposition of the delivery catheter could be confirmed using contrastmedium. A delivery device or cable is passed through a loader and thedevice 300′ screwed clockwise onto the tip of the delivery device. Onceattached, the delivery device and loader may be immersed in salinesolution, and the delivery device pulled into the loader. The guidewiremay be slowly removed from the delivery catheter and back-bleedingallowed through the side arm valve to purge air from the deliverysystem. The loader may be introduced into the catheter and withoutrotation, the device 300′ may be advanced to the distal tip of thecatheter.

The distal disk may be deployed and the system slowly retracted untilthe distal disk conforms to the vessel wall. The placement of the diskcould be confirmed using fluoroscopy. While maintaining tension on thedelivery device, the cylindrical segment and proximal disk may bedeployed by retracting the delivery catheter. A test injection could beperformed following deployment of the device in order to verify theposition thereof.

While a preferred embodiment of the present invention has beendescribed, it should be understood that various changes, adaptations andmodifications may be made therein without departing from the spirit ofthe invention and the scope of the appended claims. For example, it isanticipated that in a double disk design that it may be desirable thatonly one end of the device have a small transition diameter between thedisk and the adjacent middle cylindrical portion. The disks could alsobe other geometrical shapes if desired. It is also anticipated that thecylindrical middle or body portion may be non-concentric to one or bothdisks. It is further anticipated that the cylindrical portion could bevarious geometrical shapes, such as barrel shaped, concave, convex,tapered or a combination of shapes without departing from the inventionherein. Likewise the cylindrical portion distal and proximal ends couldhave differing shapes, such as a recessed conical shape.

Embodiments of the present invention may provide several advantages. Forexample, a smaller, lower profile device that can fit through a 4 Frenchcatheter potentially allows treatment of pre-mature infants with a PDA,while current techniques typically require surgery. In addition, thedevice is capable of decreasing the time for occluding a vessel, lumen,channel, hole, cavity, or the like in about 1 minute or less. Moreover,the device may be capable of treating more morphologies and hasincreased conformability in order to decrease the incidence of devicelengthening, thereby maintaining fixation of the device within thevessel, lumen, channel, hole, cavity, or the like. Furthermore, thedevice may be delivered bi-directionally for treating a PDA, i.e.,delivery via the pulmonary artery or the aortic artery.

Many modifications and other embodiments of the invention set forthherein will come to mind to one skilled in the art to which thisinvention pertains having the benefit of the teachings presented in theforegoing descriptions and the associated drawings. Therefore, it is tobe understood that the invention is not to be limited to the specificembodiments disclosed and that modifications and other embodiments areintended to be included within the scope of the appended claims.Although specific terms are employed herein, they are used in a genericand descriptive sense only and not for purposes of limitation.

That which is claimed:
 1. A medical device for occluding a patent ductusarteriosus, the medical device comprising: a tubular member havingproximal and distal ends and comprising at least one plane of occlusion;wherein the at least one plane of occlusion is configured tosubstantially occlude the patent ductus arteriosus in less than about 1minute.
 2. The medical device of claim 1, wherein the tubular membercomprises a disk shaped portion having a first cross-sectional dimensionon at least one of the proximal and distal ends and an adjacentgeometrical shaped portion having a second cross-sectional dimensionsmaller than the first cross-sectional dimension.
 3. The medical deviceof claim 2, wherein the geometrical shaped portion is a cylinder.
 4. Themedical device of claim 2, further comprising a transition segmentdisposed between the disk shaped portion and the geometrical shapedportion, wherein the disk and geometrical shaped portions are connectedby the transition segment having a cross-sectional dimension smallerthan both the disk diameter and geometrical shaped portioncross-sectional dimension.
 5. The medical device of claim 4, wherein thetubular member comprises a frustroconical shaped disk on each of theproximal and distal ends, and wherein the geometrical shaped portion isdisposed therebetween and connected to the frustroconical shaped diskswith respective transition segments.
 6. The medical device of claim 1,wherein the tubular member comprises at least one layer of braidedfabric comprising a plurality of braided metal strands.
 7. The medicaldevice of claim 6, wherein the tubular member comprises a plurality oflayers of braided fabric, each layer comprising a plurality of braidedmetal strands.
 8. The medical device of claim 6, wherein the metalstrands comprise a material selected from the group consisting ofstainless steel, nickel based, cobalt based, nickel-titanium, shapememory, and super-elastic materials.
 9. The medical device of claim 1,wherein the tubular member is configured to be constrained within acatheter having an outer diameter of about 5 French or smaller forpercutaneous delivery.
 10. The medical device of claim 1, wherein thetubular member comprises a plurality of planes of occlusion.
 11. Themedical device of claim 10, wherein a plurality of planes of occlusionare configured to be positioned outside of the patent ductus arteriosusand a plurality of planes of occlusion are configured to be positionedwithin a cavity defined by the patent ductus arteriosus.
 12. A medicaldevice for occluding a patent ductus arteriosus, the medical devicecomprising: a tubular member having proximal and distal ends andconsisting of a single layer of braided fabric; wherein the single layerof braided fabric is configured to be constrained within a catheterhaving an outer diameter of about 5 French or smaller for percutaneousdelivery to the patent ductus arteriosus.
 13. The medical device ofclaim 12, wherein the tubular member comprises a disk shaped portionhaving a first cross-sectional dimension on at least one of the proximaland distal ends and an adjacent geometrical shaped portion having asecond cross-sectional dimension smaller than the first cross-sectionaldimension.
 14. The medical device of claim 13, further comprising atransition segment disposed between the disk shaped portion and thegeometrical shaped portion, wherein the disk and cylindrical portionsare connected by the transition segment having a cross-sectionaldimension smaller than both the disk diameter and geometrical shapedportion cross-sectional dimension.
 15. The medical device of claim 12,wherein the single layer of braided fabric comprises a plurality ofbraided metal strands.
 16. The medical device of claim 12, wherein thetubular member is configured to be constrained within a catheter havingan outer diameter of about 4 French or smaller for percutaneousdelivery.
 17. The medical device of claim 16, wherein the metal strandscomprise a material selected from the group consisting of stainlesssteel, nickel based, cobalt based, nickel-titanium, shape memory, andsuper-elastic materials.
 18. The medical device of claim 12, wherein thetubular member comprises at least one plane of occlusion configured tosubstantially occlude the patent ductus arteriosus in less than about 1minute.
 19. A delivery system for delivering a medical device foroccluding a patent ductus arteriosus, the delivery system comprising: adelivery device coupled to the medical device, wherein the medicaldevice consists of a single layer of braided fabric; and a catheterconfigured to overlie the delivery device and constrain the medicaldevice therein, wherein the medical device is configured to be deployedfrom the catheter, and wherein the delivery device and catheter areconfigured to be delivered bi-directionally to the patent ductusarteriosus either transarterially or transvenously and to deploy themedical device at least partially within the patent ductus arteriosus.20. The delivery system of claim 19, wherein the medical devicecomprises a plurality of planes of occlusion configured to be positionedoutside of the patent ductus arteriosus and a plurality of planes ofocclusion configured to be positioned within a cavity defined by thepatent ductus arteriosus.
 21. The delivery system of claim 19, whereinthe catheter has an outer diameter of about 5 French.
 22. The deliverysystem of claim 19, wherein the catheter has an outer diameter of about4 French or smaller.
 21. The delivery system of claim 19, wherein thedelivery device and catheter are configured to be delivered to thepatent ductus arteriosus over a guidewire.
 22. The delivery system ofclaim 19, wherein the catheter is axially displaceable relative to thedelivery device such that the medical device is configured to bedeployed from the catheter in response to displacement of the catheterwith respect to the delivery device.
 23. The delivery system of claim19, wherein the medical device is configured to substantially precludethe patent ductus arteriosus in less than about 1 minute.
 26. A methodfor occluding a patent ductus arteriosus, the method comprising:providing a medical device consisting of a single layer of braidedfabric; constraining the medical device from a preset expandedconfiguration to a reduced configuration; positioning the constrainedmedical device in a catheter, the catheter and device configured to bedelivered bi-directionally, either transarterially or transvenously;delivering the medical device to the patent ductus arteriosus eithertransarterially or transvenously; and deploying the medical device fromthe catheter at least partially within the patent ductus arteriosus suchthat the tubular member returns to the preset expanded configuration.27. The method of claim 26, wherein the medical device comprises aplurality of planes of occlusion, and wherein deploying comprisesdeploying the medical device such that at least one plane of occlusionis positioned outside the patent ductus arteriosus and at least oneplane of occlusion is positioned within a cavity defined within thepatent ductus arteriosus.
 28. The method of claim 26, wherein deployingcomprises detaching a delivery system positioned within the catheter andcoupled to the medical device.
 29. The method of claim 26, whereindelivering comprises delivering the medical device over a guide wire.30. The method of claim 26, further comprising imaging the patent ductusarteriosus using at least one of two-dimensional intracardiacechocardiography, angiography, magnetic resonance imaging,transesphogeal echocardiograpy, or Doppler color flow mapping.
 31. Themethod of claim 26, further comprising verifying occlusion of the patentductus arteriosus by injecting a radiopaque contrast media through thecatheter and into the aorta downstream of the deployed medical deviceand observing with angiography whether contrast enters the cavitydefined by the patent ductus arteriosus and further whether any contrastwithin the cavity is stagnant.